Immunovant reported topline results from two Phase 3 “GO” studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease (TED). Both trials failed to meet the prespecified primary endpoint of achieving a ≥2 mm proptosis responder rate at Week 24 following a regimen of 12 weeks of high-dose batoclimab and 12 weeks of low-dose treatment. Despite the efficacy miss, safety findings were consistent with prior studies and no new safety signals were identified.
According to Immunovant, patients experienced greater proptosis improvement from baseline during the initial 12-week high-dose period than during the subsequent low-dose phase, which the company says supports the benefit of deeper IgG suppression. In a subset of hyperthyroid patients enrolled in the TED trials, thyroid hormone normalization rates were similar to those observed in the earlier Phase 2 study of batoclimab in Graves’ disease.
Immunovant reiterated that it remains focused on the rapid advancement of IMVT‑1402, its next‑generation FcRn blocker, across multiple autoimmune indications, with Graves’ disease identified as a key strategic priority. The company highlighted recent Phase 2 proof‑of‑concept data supporting FcRn blockade as a potentially disease‑modifying approach in Graves’ disease and expects topline data from potentially registrational IMVT‑1402 studies in this indication in 2027.
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